Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies

Ivermectin Clinical Trial

— GALECRUSTED  

Official title:

A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841215
• Other study ID #: P140939
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2017
• Est. completion date: January 12, 2022

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 12, 2022
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients = 18 years old, diagnosed with severe forms of scabies

1. clinical criteria : cutaneous lesions of scabies

• crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
• profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis

2. paraclinical criteria:

• Positive parasitological test
• and/or dermoscopic exam with signs of scabies Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme

Exclusion Criteria:

• Pregnant and/or breastfeeding women
• Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
• Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
• Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
• Participation in other biomedical drug research
• Patient deprived of freedom
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Related Conditions & MeSH terms

• Gale
• Ivermectin
• Oral Parasitic Drug
• Scabies
• Severe Forms of Scabies

Intervention

Drug:
• Ivermectin 200 µg/kg
Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)
• Ivermectin 400 µg/kg
Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams	Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days	Days 21+/-2 days
Primary	Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions		Days 28+/- 2 days
Secondary	Rate of adverse effects		Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days

External Links

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